Case Definition Companion Guides
SPEAC’s Case Definition Companion Guides support the use of Brighton Collaboration Case Definitions.
Standard data abstraction forms, specific to the case definition level of certainty criteria, are available for use in background incidence studies and case-control or cohort studies testing for possible vaccine-event causality.
A glossary ensures a common understanding of key clinical terms that apply to reaching specific levels of certainty.
A guided approach to organizing and interpreting safety data helps determine the level of certainty of the case definition.
Guidance for real-time data collection and investigation helps ensure the highest possible level of certainty for the case definition. Additional resources support scientific, epidemiologic and pharmacovigilance studies of a given adverse event.
The companion guides include ICD-9, ICD-10, MedDRA and SNOMEDCT codes for use in database coding or administrative data case finding, data on background incidence in global populations, and evidence for known risk factors for the event, including data on possible or proven vaccine-event associations.